Mouthpiece, nasal seal, head appliance, apparatus, and methods of treating sleep apnea

ABSTRACT

A CPAP device and a method for treating sleep apnea use a head appliance with an oral adaptor comprising a tube partially inserted in a person&#39;s mouth and a diaphragm applied over the tube against the mouth, such that the lips are formed into a tight seal with the tube. A nasal seal is described comprising two rollers to which a strap is attached, so that the nasal seal is easily put in place, adjusted and maintained by rolling the rollers on the nose sides or pulling the straps.

BACKGROUND

[0001] Sleep apnea is a common sleep ailment that affects as many asfive percent of the population worldwide. Persons with sleep apnea stopbreathing for short durations many times during sleep, so that the depthand quality of their sleep is reduced. As a result, persons with sleepapnea suffer from a profound sleepiness, which can impair their abilityand performance at work and in other activities.

[0002] Sleep apnea often results from a collapse of the person's throattissues during sleep, which reduces or suppresses the air flow to thelungs. Lowered oxygen levels and increased carbon dioxide levels inblood alert the person's brain and breathing resumes, but eachoccurrence arouses the person and interrupts restorative sleep.

[0003] Surgery is a possible treatment but surgical procedures arecomplex and success rates are often low. A more common treatment forsleep apnea is to force air inside the person's throat during sleep witha respirator apparatus. Apparatuses of this type use continuous positiveairway pressure or CPAP.

[0004] Respirator apparatuses traditionally provide pressurized air orgas to a nasal mask which is applied to the persons' nose during sleep.However, nasal masks are difficult to apply on a person's nose, whichresults in skin irritation, nasal congestion, airways dryness, and airleaks. In addition, nasal masks are bulky, so that the person wearingthe mask cannot move easily and may experience claustrophobia.

SUMMARY OF THE INVENTION

[0005] In view of the above, there is a need for an apparatus allowing aperson having sleep apnea to breathe regularly without interruptionduring sleep, which is easy and comfortable to wear, does not leakunintentionally, and effectively maintains the open state of theairways.

[0006] The present invention provides such an apparatus. In particular,the present invention provides an oral adaptor or mouthpiece that allowsa respirator to apply positive pressure in a person's airways withoutleaks and without irritation or congestion, and a nasal seal or sealthat is easy and comfortable to wear and effectively avoidsunintentional leaks. The present invention also provides a headappliance that includes such a mouthpiece and a nasal seal, as well asan apparatus and method for treating sleep apnea or symptoms of sleepapnea.

[0007] In an aspect of the present invention, an oral adaptor for a CPAP(Continuous Positive Airway Pressure) device comprises: an oral inserthaving a passage therein, comprising an insertion portion to be insertedinto a person's mouth and a connection portion for connecting the oralinsert to a CPAP respirator, and a sealing element to be placed on theperson's mouth, wherein the sealing element is a flexible material suchthat the person's lips form a seal on the oral insert. In someembodiments, the sealing element can be a diaphragm or a pad.

[0008] In another aspect of the present invention, an oral adaptor to beapplied to a person's mouth comprises: a tubular portion having aninsertion end to be inserted in a person's mouth and a connection end tobe connected to a source of positive pressure, and a first surface whichfaces an inner side of a person's lips, and a second surface which facesan outer side of the person's lips, when the oral adaptor is applied tothe person's mouth, such that the person's lips are conformed betweenthe second surface and at least one of the tubular portion and the firstsurface when a positive pressure is created inside the mouth to form aseal with the oral adaptor.

[0009] In another aspect of the present invention, a nasal seal for aCPAP device comprises two curved pieces to be placed on respective sidesof a person's nose, which are connected to each other so as to leave aspace between the curved pieces for the person's nose, wherein a holdingstrap is attached to the nasal seal for application on the person'snose. In one embodiment, the curved pieces are rollers rotatable aroundrespective axes, the axes being connected to each other so as to leave aspace between the rollers for the person's nose.

[0010] In another aspect of the present invention, a head appliancecomprises an oral adaptor or a mouthpiece as described above, a nasalseal as described above, or both.

[0011] In another aspect of the present invention, a head appliance fora CPAP device comprises: a mouthpiece having an insertion portion to beinserted in a person's mouth and a connection portion to be connected toa CPAP respirator, a connection tube having an end connected to theconnection portion of the mouthpiece, a head strap to be placed over apersons' head, and a tube support element attached to the head strap forsupporting the connection tube.

[0012] In yet another aspect of the present invention, a CPAP devicecomprises a head appliance as described above connected to a CPAPrespirator.

[0013] In a further aspect of the present invention, a method fortreating symptoms of sleep apnea in a person comprises: inserting aninsertion portion of an oral insert in the person's mouth, applying asealing element on the person's mouth so that the person's lips form atight seal around the insertion portion of the oral insert, andconnecting the oral insert to a source of positive pressure.

[0014] In another aspect of the present invention, a method for treatingsymptoms of sleep apnea in a person comprises: inserting an insertionportion of an oral insert in the person's mouth such that a firstsurface of the insertion portion faces an inner side of the person'slips, applying a sealing element on the person's mouth such that asecond surface faces an outer side of the person's lips, so that thelips form a tight seal around the insertion portion of the oral insert,and connecting the oral insert to a source of positive pressure.

[0015] In various embodiments, advantages of the present invention mayinclude: the smaller overall size of the head gear, which facilitatesmovements of the sleeper, the absence of nasal CPAP, which reducesairways irritation and congestion, the reduction or elimination ofunintentional leaks, which avoids airways dryness and improvesefficiency, the ease of application of the head gear and the softness ofthe contact between the elements of the head gear and the skin, whichmakes wearing the head gear more comfortable. The nasal seal is able tobe removed easily. In particular, the present invention can make itpossible to essentially eliminate unintentional leaks.

BRIEF DESCRIPTION OF THE FIGURES

[0016]FIG. 1 is a front view of a first embodiment of a head applianceaccording to the present invention mounted on a person's head;

[0017]FIG. 2 is a side view of the head appliance of FIG. 1;

[0018]FIG. 3A is a vertical cross-sectional view of the head applianceof FIG. 1 along line 3-3 of FIG. 1;

[0019]FIG. 3B is a horizontal cross-sectional view of an oral adaptor ofthe head appliance along line B-B of FIG. 3A;

[0020]FIG. 3C is a perspective view of the oral adaptor of FIG. 3B;

[0021]FIG. 3D is a view of the oral adaptor of FIG. 3B along arrow D onFIG. 3B;

[0022]FIG. 3E is a schematic partial vertical cross-sectional view ofthe head appliance of FIG. 1 along line 3-3 of FIG. 1 without adiaphragm to show lip positions;

[0023]FIG. 4 is a side view of a second embodiment of a head applianceaccording to the present invention, further comprising a jaw strapmounted on the person's head;

[0024]FIG. 5 is a front view of a third embodiment of a head applianceaccording to the present invention, further comprising a nasal sealmounted on the person's head;

[0025]FIG. 6 is a side view of the head appliance of FIG. 5;

[0026]FIG. 7 is a side view of a fourth embodiment of a head applianceaccording to the present invention, further comprising a head strap anda connection tube;

[0027]FIG. 8 is a front view of the head appliance of FIG. 7;

[0028]FIG. 9A is a partial perspective view of the nasal seal of FIG. 7;

[0029]FIG. 9B is a schematic partial horizontal cross-sectional view ofthe head appliance of FIG. 7 along line 9-9 on FIG. 8 showing thepositioning of the nasal seal on the nose;

[0030]FIG. 10 is a schematic view of a CPAP apparatus connected to thehead appliance of FIG. 7;

[0031]FIG. 11 is a front view of a fifth embodiment of a head applianceaccording to the present invention without a lower diaphragm supportstrap;

[0032]FIG. 12 is a side view of the head appliance of FIG. 11;

[0033]FIG. 13 is a cross-section al view of the head appliance of FIG.11 along line 13-13 of FIG. 11;

[0034]FIG. 14 is a front view of the head appliance of FIG. 11 with thelower diaphragm support strap;

[0035]FIG. 15 is a side view of the head appliance of FIG. 11 with thelower diaphragm support strap;

[0036]FIG. 16 is a side view of a sixth embodiment of a head applianceaccording to the present invention, further comprising a nasal seal;

[0037]FIG. 17 is a front view of the head appliance of FIG. 16;

[0038]FIG. 18 is a side view of a seventh embodiment of a head applianceaccording to the present invention, further comprising a nasal seal;

[0039]FIG. 19 is a front view of the head appliance of FIG. 18;

[0040]FIG. 20 is a front view of an eighth embodiment of a headappliance according to the present invention, further comprising aconnecting hose support;

[0041]FIG. 21 is a side view of the head appliance of FIG. 20;

[0042]FIG. 22 is a front view of a ninth embodiment of a head applianceaccording to the present invention, further comprising pressure elementsand a jaw strap, shown without a jaw strap;

[0043]FIG. 23 is a front view of the head appliance of FIG. 22, shownwith the jaw strap;

[0044]FIG. 24 is a side view of the head appliance of FIG. 23;

[0045]FIG. 25 is a front view of a tenth embodiment of a head applianceaccording to the present invention, further comprising a tube holdingstrap;

[0046]FIG. 26 is a side view of the head appliance of FIG. 25;

[0047]FIG. 27 is a front view of an eleventh embodiment of a headappliance according to the present invention, further comprising a nasalseal and a connecting hose support; and

[0048]FIG. 28 is a side view of the head appliance of FIG. 27.

DESCRIPTION OF PARTICULAR EMBODIMENTS

[0049] FIGS. 1-3 show a first embodiment of a head appliance for a CPAPdevice according to the present invention, which is mounted on aperson's head. The head appliance comprises an oral adaptor 1, which isapplied as a mouthpiece to the mouth of the person. The oral adaptor 1is partially inserted into the person's mouth and is maintained againstthe person's mouth by a first strap2 and a second strap 3 passed aroundthe person's head.

[0050] The oral adaptor comprises a tube 4, which defines a passage 5for air or gas having an opening 6 inside the mouth and an opening 7outside the mouth. The tube has the general shape of an L. One branch ofthe L forms an insertion portion 8 that is inserted into the person'smouth. The other branch of the L defines a connection portion 9 forconnecting the oral adaptor to an air or gas supply hose of an apparatusfor applying a positive pressure to the airways by means of pressurizedair or gas. Also, an exhaust port is located on the tube or between thetube and the apparatus for applying a positive pressure. In thisembodiment, the oral adaptor is connected to the supply hose by asnapped connection, which makes it easy to connect and disconnect theoral adaptor to the supply hose. The insertion portion 8 carries aperipheral flange 12, which is positioned between the teeth (not shown)and the inner sides of the person's lips. Thus, the inner sides of thelips face a surface 13 of the peripheral flange that is oriented towardthe corner of the L shape. The peripheral flange 12 has substantially abutterfly shape in this embodiment and the insertion portion 8 of thetube has an oval shape in the area where it meets the peripheral flange.Further, the flange 12 is advantageously dimensioned so as to fill thespace between the lips and the teeth and gums around the mouth, and theouter edge of the flange is tapered, rounded, or both tapered androunded, so as to protect the adjacent mouth tissues and to improve thesealing effect of the inner lips against the flange.

[0051] At least one biting bit 14 is located at the inner end of theinsertion portion to aid positioning of the oral adaptor in the mouth.For example, two biting bits, each having a mushroom shape, are attachedat the inner surface of the peripheral flange 12 on the sides of the airor gas passage as shown on FIG. 3. An oral insert comprising a tube witha flange and biting bits is sold for example as part of a snorkel underthe mark AIR DRY by the TECHNISUB company. Advantageously, the bitingbit heads have rectangular shapes and extend to the outer periphery ofthe flange on each side, and the biting bit leg has dimples that allowthe teeth to grip it.

[0052] In a variant (not shown), the exhaust port is located on a tubesection branched on the tube of the oral adaptor, for example in thearea of the L corner. In that case, the oral adaptor can havesubstantially a T shape. One branch of the T defines the insertionportion and a second branch of the T defines a connection portion forconnecting the oral adaptor to the apparatus for applying a positivepressure, as in the tube having a L shape. However, in this variant, theexhaust port is located on the third branch of the T. This variantreduces the amount of expelled carbon dioxide that returns to the mouthupon inhalation.

[0053] On the outer side of the lips is applied a sealing element in theform of a diaphragm 15. The diaphragm 15 is large enough so as tocompletely cover the mouth and the lips from the outside. In thisembodiment, the diaphragm 15 extends beyond the outer limit of the lips.The diaphragm is made of flexible material so that its shape conformsitself to the shape of the outer side of the lips when the diaphragm isapplied to the lips. The diaphragm has a hole 16 for passing it over thetube. Preferably, the hole 16 has a shape and dimension equal to or lessthan those of a cross-section of the tube 4 at the location of the lips,so that a tight fit is provided between the diaphragm 15 and the tube 4when the diaphragm is applied to the lips. The diaphragm is separatefrom the tube. In the alternative, the diaphragm could be integral with(such as by molding) or attached to the tube, for example by a glue,tape or staple connection, although care should be taken to avoidconfigurations that unduly irritate the skin.

[0054] Advantageously, the diaphragm 15 is less rigid than theperipheral flange 12 on the insertion portion 8 of the tube 4. Thus, theinner side of the lips is applied against the surface of the peripheralflange 12 when the insertion portion is positioned inside the mouth, andthe outer side of the lips is firmly maintained without excessivepressure by the diaphragm 15 covering the mouth. As a result, the lipsform a tight seal without leak against the tube 4, or at least betweenthe peripheral flange 12 and the diaphragm 15. An even tighter seal isobtained by application of petroleum jelly or like substance in thespace between the peripheral flange and the diaphragm where the lipssurround the tube 4, on the tube itself, and/or on the lips, or by thesecretion of saliva in these locations.

[0055] Preferably, the diaphragm is elastic, so that the diaphragm canstretch and/or contract to an appropriate degree before, during and/orafter positioning of the diaphragm on the lips in order to obtain atighter seal with the lips, or with the skin around the lips. Forexample, the diaphragm can be positioned over the lips and pulled by itssides to extend the elastic material, and then allowed to contract. Forthe present purposes, elastic materials are defined as materials that,when stretched 10% (more preferably 50%), for one hour, in a direction,at room temperature, experience less than 5% permanent deformation afterthe stress is removed. In a preferred embodiment, the elastic materialcomprises latex. It has been discovered that an elastic diaphragmresults in a superior seal as compared to an inelastic diaphragm.Preferred materials for the diaphragm are non-porous, elastic materialsthat do not irritate the skin, for example natural rubber latex sold asunder the mark THERABAND.

[0056] The first strap 2 maintains the tube in its position applied tothe mouth. The first strap is attached to the tube 4 and passes aroundthe person's head above the ears. Advantageously, the first strap 2 isattached to the tube 4 at a location as close as possible to the mouth,in particular, closer to the insertion portion than to an end of theoral insert opposed to the insertion portion, so that the insertionportion 8 is pulled by the strap toward the upper teeth while avoiding alever effect which would pull the insertion portion 8 away from thebottom teeth. Also, the biting bit or bits 14 are maintained in contactwith the upper teeth. At least one end of the first strap is attached tothe tube 4 on the branch of the L shape which carries the insertionportion 8, i.e., closer to the insertion portion 8 than to the oppositeend of the tube. The other end of the first strap 2 can be attached tothe same location, or to the other branch of the L shape, which carriesthe connection portion 9, as shown on FIG. 1. Thus, the first strapconstitutes a tube holding strap.

[0057] The second strap 3 passes around the person's head under the earsand maintains the diaphragm 15 against the outer side of the lips. Thesecond strap 3 is not attached to the diaphragm 15, but comprises anenlarged portion 17 with a hole 18, which is passed over the tube 4 andapplied against the diaphragm 15 to maintain the diaphragm against thelips. Thus, the second strap constitutes a diaphragm strap. The enlargedportion 17 of the second strap is advantageously flexible or elastic soas to conform itself to the shape of the diaphragm, i.e., to the shapeof the outer side of the lips. However, the enlarged portion 17 can beof a less flexible or less elastic material than the diaphragm, providedthe enlarged portion is flexible enough to maintain the diaphragmagainst the lips so as to avoid leaks. In an alternative embodiment, thesecond strap could be attached to the diaphragm, for example, by tapingthe diaphragm to the strap.

[0058] The enlarged portion of the second strap applies the diaphragmagainst the lips with a weak force that is intended to be sufficient tocompensate forces tending to pull the insertion portion away from themouth without compressing the mouth to a level which would damage thelips, gums or teeth, or other parts of the mouth. More specifically, thesecond strap applies forces 19 and 20 that are directed so as to pushthe lips toward the flange 12 and toward the tube 4, with the forcecomponent directed toward the tube (vertical component on FIG. 3E) iscomparable to the force component directed toward the flange (horizontalcomponent on FIG. 3E). In the case of an elastic diaphragm, the forcesare preferably sufficient to maintain the diaphragm in an appropriatelyextended state, so as to obtain a tight seal with the lips or with theskin around the lips.

[0059] In a variant of this embodiment, the diaphragm could be integralwith or attached permanently or removably to the second strap. However,in the present embodiment, the diaphragm extends above and below theenlarged portion of the second strap to facilitate positioning andapplication over the lips without folds or creases, and, in the case ofan elastic diaphragm, to facilitate pulling the sides of the diaphragmin order to obtain a tighter seal.

[0060] Each strap has a ribbon shape and is adjustable in length, forexample, by elasticity or with Velcro® (hooks and loops), with a buckle,with an elastic portion, with buttons, or combinations of these. It isnoted that several variants are possible for the straps other than theones described above. Thus, in alternative embodiments, each or both ofthe first strap and second strap are attached to a part of the oraladaptor or are separate from the oral adaptor, only one strap or morethan two straps are provided, or the oral adaptor is held between theperson's lips without any strap. Each of the straps may be elastic orcomprise an elastic portion, or it may have a length that does not varybetween adjustments. Suitable materials for the straps or portions ofthe straps include, but are not limited to, fabric, flexible material,for example plastic, and an elastic material such as rubber.

[0061]FIG. 4 shows a second embodiment of a head appliance according tothe present invention, which is identical to the head appliance of FIGS.1-3 except that a jaw strap 21 is provided around the person's head overthe first and second straps. The jaw strap 21 has a ribbon shape andpasses above the ears and over the chin. In the area of the chin, thejaw strap is divided in two segments 22 and 23, one above a central partof the chin, the other under a central part of the chin, so that thecentral part of the chin is not covered by the jaw strap.

[0062] An advantage of the jaw strap 21 is that it prevents the lowerjaw from dropping excessively, as occurs for some persons when theysleep, which could create leaks. The jaw strap can also help inmaintaining the diaphragm by pressing its lower portion against theperson's skin under the mouth. Additionally, the jaw strap passes overthe cheeks, so as to prevent ballooning of the cheeks, which couldloosen the lips from around the tube. Thus, the jaw strap complementsthe other straps, in particular the second strap, which may preventballooning of tissue around the lips. In the alternative, the jaw strapcould be provided to fulfill only some of these objectives.

[0063] In addition, at least one pressure element or portion 24 (shownin dotted line on FIG. 4) is located on the person's face over thecheeks beyond the location facing the extremities of the peripheralflange, for example at opposite ends of the diaphragm or under one ofthe straps. In a preferred embodiment, there is a larger peripheralflange so that the sealing elements do not extend beyond the locationfacing the extremities of the flange. The pressure portions 24 arepressed by the strap or straps against the cheeks and tend to push thecheeks inward, which improves the seal formed by the lips between theperipheral flange 12 and the diaphragm 15 and between the tube 4 and thediaphragm 15. The pressure portions 24 may be unattached or attached toanother part of the device, for example the diaphragm or one of thestraps, for example the diaphragm strap 3 or the jaw strap 17.

[0064] FIGS. 5-6 show a third embodiment of a head appliance accordingto the present invention, which is identical to the head appliance ofFIG. 4 except that a nasal seal 25 is provided on the person's nose. Thenasal seal is applied to both sides of the nose to close the nostrilsand is maintained by a nasal seal strap 26 that passes around theperson's head.

[0065] An embodiment of a nasal seal is shown in more detail in FIG. 9.It comprises two curved pieces 27 and 28 disposed at a distance fromeach other. In the embodiment described in the figures, the curvedpieces are rollers rotatable around axes, which are connected at theirends by at least one connection member, preferably elastic members 29and 30, so that an adjustable space for the nose is defined between therollers. In a variant, each of the cylinders has an aperturetherethrough, and the elastic connection comprises an elastic band thatmoves through the aperture in each cylinder. The rollers are preferablymade or comprise at least a layer or a portion of a flexible material,for example an elastic material. Advantageously, the ends of the nasalstrap are connected to the rollers such that the rollers are rotated inopposite direction when the nasal strap is pulled, as shown by the upperarrows 31 and 32 on FIG. 9B.

[0066] The rollers close the nostrils primarily by applying shear forcesto the skin next to the base of the nose, which tends to pull the skinnext to the nose on both sides of the nose toward the base of the nose,as shown by the lower arrows 33 and 34 on FIG. 9B. In other words, therollers are located in the corners formed by the nose faces and the skinadjacent to the nose base without directly pressing on the nose itself.Thus, a perfect seal can be obtained without any compressive force onthe nose itself, which protects the fragile skin of the nose from beingdamaged when the nasal seal is applied for long periods of time, forexample, a full night. In a variant, the rollers secondarily apply aslight compressive force to a region of the nose closer to the tip asshown by the middle arrows 35 and 36 on FIG. 9B, so as to close thenostrils in that region. In another variant, the rollers are locatedagainst the nose faces and apply a compressive force appropriate toclose the nostrils so as to obtain an airtight seal. In that case, thenasal seal can be applied against the nose faces without touching thebase of the nose. Any remaining opening can be filled with petroleumjelly so as to obtain a perfect seal.

[0067] The nasal strap 26 helps obtain or maintain a good positioning ofthe rollers 27 and 28 against the nose because if the rollers are movedaway from the person's face, the strap pulls the rollers, which tends tomake them roll toward the face. As a result, a tight seal is obtainedwithout applying a strong force on the nose or around the head. Forexample, as shown on FIG. 9A, the strap ends are connected to and rolledaround the peripheral surface of the rollers. The nasal strap can havefeatures similar to the other straps described above. The strap ends arepreferably a soft material 37 that does not irritate the skin.

[0068] The proper balance between forces, i.e., to obtain high shearforce and low compressive force, is obtained by adjusting one of severalof (a) the circumference of the rollers, (b) the cleanliness of the face(no greasiness), (c) the nature of the roller surface (high coefficientof friction), (d) the size and elastic properties of the elasticmembers, (e) the elastic properties of the holding strap, and (f) theamount of tension of the holding strap.

[0069]FIGS. 7 and 8 show a fourth embodiment of a head applianceaccording to the present invention, which is identical to the headappliance of FIGS. 5-6 except that it additionally comprises aconnection hose 38 connected to the tube 4 of the oral adaptor 1 forconnecting the head appliance to the source of positive air or gaspressure or to a respirator. The connection hose 38 is preferably madeof a flexible or elastic material and able to change shape, so thatmovements of the person's head are not prevented, but is sufficientlyrigid to maintain a passage for air or gas from the respirator, inparticular when it is submitted to radial or torsional forces.Advantageously, the oral adaptor can freely rotate with respect to theconnection hose.

[0070] A head band 39 passes around the person's head above the ears andthe face. A hose support 40 is attached to the head band on the sameside of the head as the connection portion of the oral adaptor. The hosesupport is in the shape of an open or closed ring that defines a passage41 for the connection hose. The connection hose can slide and rotateinside the ring. However, in the case of an open ring, the diameter ofthe connection hose is larger than the width of the cut portion of thering, so that the connection hose cannot be removed through the cutportion of the ring, except by collapsing the hose or by widening thecut portion of the ring when the ring is not completely rigid. The headband is, for example, a conventional elastic head band, and the hosesupport is, for example, a snorkel hose support from a snorkel soldunder the mark AIR DRY by the TECHNISUB company.

[0071] The exhalation port is mounted on the connection portion of theoral adaptor between the tube and the connection hose. For example, theexhalation port is located on a connection section which is freelyrotatable with respect to at least one of the oral adaptor and theconnection hose for the CPAP respirator. In a variant not shown, theexhalation port could be located on a branched passage opening in thepassage between the insertion portion and the connection portion. Theexhalation port allows expired air to exit the passage but prevents airfrom the outside to penetrate into the passage. A suitable exhalationport (for example, 10, 11 in FIG. 1) is sold for example under the markWHISPER SWIVEL by the RESPIRONICS company.

[0072]FIG. 10 shows schematically an embodiment of a respirator 42 thatis connected to a head appliance according to the present invention toprovide a source of positive pressure. The respirator comprises a CPAPdevice 43 that creates positive pressure. The respirator is operatedwith electric power through an electric wire 44 which may be plugged toa power outlet (not shown). The respirator provides a positive pressureto an outlet 45. A suitable respirator is for example the CPAP machinesold under the RESPIRONICS mark.

[0073] An end of a first hose 46 is connected to the outlet of the CPAP.Thus, positive air or gas pressure is created inside the first hose. Ahumidifier 47 has an inlet 48 connected to the other end of the firsthose and an outlet 49 connected to an end of a second hose 50. Thus, airor gas having positive pressure and adjusted humidity content is presentin the second hose. The second hose supplies air or gas to theconnection hose of the head appliance or directly to the exhalationport, or the second hose constitute the connection hose. Given theabsence of unintentional leaks, the humidifier can be omitted unless theperson desires additional humidification of the inhaled air or gas.

[0074] The head appliance according to the above embodiments isadvantageously positioned on the person's head as follows.

[0075] As a preliminary step, the person can apply petroleum jelly orthe like in the nostrils and lip balm on the inner part of the outerlips. The person then prepares the insertion portion by passing thediaphragm over the tube, through the diaphragm hole, in the case of anunattached diaphragm.

[0076] Next, as a first positioning step, the person inserts theinsertion portion of the oral adaptor into her mouth with the peripheralflange between the teeth and the lips, and places her lips around thetube.

[0077] Second, the person extends the diaphragm over the lips withoutfolds or creases, and passes the tube holding strap around the headabove the ears to retain the insertion portion against the upper teeth.

[0078] Third, the person passes the diaphragm strap over the tube andadjusts it around the head under the ears and over the diaphragm aboveand under the tube to maintain the diaphragm over the lips while formingthe lips against the flange and the tube of the oral adaptor. In thecase of an elastic diaphragm, the person advantageously pulls the sidesor the corners of the diaphragm so as to extend it over the lips toobtain a tighter seal.

[0079] Fourth, the person places pressure elements in appropriatelocations, if desired, then passes the jaw strap over the chin, thecheeks, and around the head above the ears, if a jaw strap is provided.

[0080] Fifth, the person puts on the nasal seal, if provided, by placingthe rollers against the facial skin adjacent to the nose, against theskin of the nose faces, or both, and by rotating the rollers toward theface and/or pulling the strap to rotate the rollers. As a result, therollers roll on the skin toward the nose base and are pulled toward eachother by the elastic members until the nostrils are totally collapsed.By adjusting the tension of the strap before or after positioning therollers, an adequate shear force can be applied by the rollers againstthe facial skin or the nose sides to maintain a secure seal withoutexcessive compressive force against the nose.

[0081] Sixth, the person connects the oral adaptor to the air or gassupply hose of the respirator. When positive pressure is applied insidethe mouth, the lips are further molded and wedged against the tubebetween the peripheral flange and the diaphragm. As a result, a secureseal can be obtained in the area of the mouth also. In the case of anelastic diaphragm, a better seal may be obtained if the diaphragm, abetter seal can be obtained if the diaphragm is again adjusted, asdiscussed above in the third step. If provided, the connection hose isconnected between the oral adaptor and the air or gas supply hose andpositioned in the hose support of the head band, which is placed aroundthe head.

[0082] FIGS. 11-15 show a fifth embodiment of a head appliance accordingto the present invention. In this embodiment also, the head appliancecomprises an oral adaptor. The oral adaptor comprises a tube and adiaphragm that are substantially similar to the tube and diaphragm ofthe first to fourth embodiments. However, this fifth embodiment isdifferent from the first to fourth embodiments in particular in that apad 51 that is dimensioned so as to cover the person's lips is appliedover the diaphragm. The pad is made of a relatively thick layer offlexible and resilient or elastic material, for example a rubber foam.The inner face 52 of the pad can cover the diaphragm partially orcompletely as shown on FIG. 13.

[0083] As in previous embodiments, the diaphragm can be unattached,integral, or attached permanently or removably to the tube. Further, thehead appliance comprises straps for supporting the tube and maintainingthe diaphragm. The tube holding strap 53 is substantially identical tothe first strap in the first to fourth embodiments. However, the otherstraps may be different from the other straps in the first to fourthembodiments. For example, the single diaphragm strap is replaced by anupper diaphragm strap 54 and a lower diaphragm strap 55. The lowerdiaphragm strap is shown on FIGS. 14-15 but not on FIGS. 11-13.

[0084] The upper diaphragm strap 54 is in the form of a band thatsurrounds the head under the ears and is applied on an upper portion ofthe sealing pad 51 above the tube, i.e., over and above the upper lipbut under the nose. The lower diaphragm strap 55 is in the form of aband that surrounds the head above the ears and is applied on a lowerportion of the sealing element 51 under the tube, i.e., over and underthe lower lip, and above or over at least a portion of the chin. Thus,the upper diaphragm strap 54 maintains the upper portion of thediaphragm against the upper lip and the lower diaphragm strap 55maintains the lower portion of the diaphragm against the lower lip. Thelower diaphragm strap 55 can also function as a jaw strap to maintainthe mouth closed during sleep, avoid ballooning of the cheeks, and applypressure portions (not shown) on the lip edges or on the cheeks.

[0085] A suitable upper diaphragm strap is sold for example as SNUG FITmodel “chin strap” by MALLINCKRODT company, and a suitable lowerdiaphragm strap is sold as CHIN STRAP model under the mark RESPIRONICS.

[0086] In this embodiment, the pad participates in distributing,equalizing, or both, the forces exerted by the upper and lower diaphragmsupport straps to the diaphragm, so as to improve the seal between thediaphragm and the lips or the skin around the lips, while protecting theskin against excessive localized pressure. Thus, the inner face 52 ofthe pad may be contoured so as to have a shape corresponding to theshape of a person's lips, for example with a central recess which can bepositioned over the lips.

[0087] FIGS. 16-17 show a sixth embodiment of the head applianceaccording to the present invention. In this sixth embodiment, the headappliance is identical to the head appliance of the fifth embodimentexcept that it additionally comprises a nasal seal. The nasal seal isidentical to the nasal seal in the third and fourth embodiments.

[0088] FIGS. 18-19 show a seventh embodiment of the head applianceaccording to the present invention, in which the head appliance isidentical to the head appliance of the sixth embodiment except that itadditionally comprises a connection hose with head band and hosesupport, which are substantially identical to those of the fourthembodiment.

[0089] In variants of the embodiments of FIGS. 11-19, as in otherembodiments of the present invention, the diaphragm extendsadvantageously below and under the maintaining elements such as strapsor pads, so as to allow adjustment of the diaphragm to avoid leaks. Thediaphragm is advantageously rectangular or oval in shape with dimensionsadapted to extend beyond the mouth on each side.

[0090] The head appliance according to the fifth to seventh embodimentsof the present invention is positioned on the person's head as follows.

[0091] First, the person places the insertion portion of the oral insertinto her mouth with the peripheral flange between the teeth and thelips, and places the lips around the tube. This operation is facilitatedwhen the person bites into the biting bits.

[0092] Second, the person fully extends the diaphragm over the mouth,then passes the tube holding strap around the head above the ears topull the insertion portion against the upper teeth.

[0093] Third, the person positions the pad over the diaphragm, thenplaces the upper diaphragm strap, for example by passing the straparound her head below the ears, and fastens it over the upper portion ofthe pad under her nose.

[0094] Fourth, the person places the lower diaphragm strap, for exampleby passing over the lower part of the pad and over the ears, thenfastening it at the top of her head. As a result, the straps cooperateto keep the pad in place, so that the diaphragm is maintained againstthe lips but is prevented from separation from the respective lips bythe pad and the straps. The actual force applied by the straps can bevery low, i.e., just sufficient to maintain the pad, and additionalpressure portions if provided, in place against the face.

[0095] Fifth and sixth, the person then puts on the nasal seal and thehead band, if provided, and connects the connection hose or the supplyhose to the oral adaptor. Once a positive pressure is created within theairways, the nasal seal can be readjusted, and the lips moved againstthe diaphragm to obtain a perfect seal around the tube with zero leaks.Advantageously, the lips are expanded and moved outward to contact thediaphragm, so that only lip tissue, not skin tissue, contact thediaphragm.

[0096] FIGS. 20-28 show additional embodiments of head appliancesaccording to the present invention, which is substantially similar tothe first to fourth embodiments except that the diaphragm is maintainedover the lips by respective upper and lower diaphragm straps 56 and 57passing around the back of the person's neck, under the ears, and overthe diaphragm above and under, respectively, the tube of the oraladaptor. Further, a jaw strap 58 and a tube holding strap 59, which areshown respectively on FIGS. 23-26 and 27-28, are additionally providedaround the person's head. Additional pressure portions are provided overthe sides of the lips or adjacent skin tissues, i.e., a first pressureportion 60 under the connection portion of the tube and a secondpressure portion 61 between the upper and lower diaphragm straps on theside of the oral adaptor opposed to the connection portion. Further, inthis embodiment, a third pressure portion 62 is applied on the secondpressure portion 61. The jaw strap is applied over at least one of thesepressure portions, here, the second and third pressure portions. Thetube holding strap is applied over the connection portion 9 of the tubeof the oral adaptor, i.e., over the first pressure portion.

[0097] Thus, the diaphragm is maintained over the lips by the upper andlower diaphragm straps 56 and 57, the mouth is kept closed by the jawstrap 58, and the oral adaptor is held by the tube holding strap 59,while ballooning effects and corresponding leaks are avoided by the jawstrap 58 and the pressure portions 60-62 on the mouth edges or on thecheeks.

[0098] In any of the embodiments shown in the figures, the tube of theoral adaptor has the connection portion on the left side of the person'sface. It will be immediately apparent that the connection portion couldalso be located on the right side, or in front of the person's mouth,the connection hose passing for example around the person's nose. Also,the oral adaptor could have two connection portions on each side of theperson's face, which could be connected alternatively to a connectionhose and a seal, or connected simultaneously to a connection hose havinga double connection end passing for example over the person's face. Inthe alternative, the connection portion or portions of the tube of theoral adaptor could have an elbow so as to direct its end toward the topof the person's head instead of toward its side.

[0099] The hose or hoses connecting the oral adaptor to the respiratorare advantageously long enough to enable movement of the person duringsleep and also to enable locating the respirator away from the person'sbed. For example, the overall length of the hose or hoses may bepreferably at least six feet.

[0100] Advantages of the head appliance according to the presentinvention include a very tight seal around the mouth without applicationof high pressure or strong forces which could irritate or damage theskin or be uncomfortable. Rather, a perfect seal is obtained “passively”by conforming the lips around the tube between the peripheral flange andthe sealing element, with the air pressure providing the force necessaryto press the lips against the sealing element. This is obtained byadjusting the forces applied by the straps so that the sealing elementapplies a relatively low pressure force on the lips toward the flangeand a relatively high shear force on the lips toward the tube. As aresult, the lips are sealed against the tube and ballooning of the lipsby the formation of air pockets between the lips and the flange areeffectively prevented without damaging the skin on and around the lips.

[0101] Particular embodiments of the present invention include one ormore of the following: the elements in contact with the skin are soft;other than the exhalation port, no element of the head appliance isrigid—so the sleeper can roll over without a rigid component creatingleverage that could create leaks; the head appliance is compact; noelement extends away from the head significantly farther from the nose,which gives more freedom of movement without leverage on the mouthpieceor nasal seal, i.e., without creating unintentional leaks. Accordingly,the head appliance is very robust. Lubrication around the lips is notnecessary, unless the person desires additional sealing. Lubricants,such as petroleum jelly, may be helpful to form a seal in the nose.

CLOSURE

[0102] While preferred embodiments of the present invention have beenshown and described, it will be apparent to those skilled in the artthat many changes and modifications may be made without departing fromthe invention in its broader aspects. For example, although eachembodiment of the head appliance is described with one type of oraladaptor and one type of nasal seal, numerous variations are possiblesuch as an oral adaptor of one embodiment and a nasal seal of anotherembodiment, and these variations are included within the scope of theinvention. In particular, a person of the art will understand that oneor several features of any of the described embodiment can be combinedor applied to another embodiment of the present invention. The appendedclaims are intended to include all such changes and modifications asfall within the true spirit and scope of the invention.

1. An oral adaptor for a CPAP (Continuous Positive Airway Pressure)device, comprising: an oral insert having a passage therein, comprisingan insertion portion to be inserted into a person's mouth and aconnection portion for connecting the oral insert to a CPAP respirator,and a sealing element to be placed on the person's mouth, wherein thesealing element is a flexible material such that the person's lips forma seal on the oral insert.
 2. An oral adaptor as claimed in claim 1,wherein the sealing element is an elastic material.
 3. An oral adaptoras claimed in claim 1, comprising at least one holding strap to beplaced around the person's head for maintaining the sealing element onthe person's mouth.
 4. An oral adaptor as claimed in claim 3, whereinthe sealing element is a diaphragm and wherein a foam pad is placedbetween the diaphragm and the at least one holding strap.
 5. An oraladaptor as claimed in claim 1, wherein the sealing element is adiaphragm.
 6. An oral adaptor as claimed in claim 1, wherein the sealingelement faces a flange of the insertion portion when the oral adaptor isapplied to the person's mouth.
 7. An oral adaptor as claimed in claim 1,further comprising an exhalation port.
 8. An oral adaptor to be appliedto a person's mouth, comprising: a tubular portion having an insertionend to be inserted in a person's mouth and a connection end to beconnected to a source of positive pressure, and a first surface whichfaces an inner side of a person's lips, and a second surface which facesan outer side of the person's lips, when the oral adaptor is applied tothe person's mouth, such that the person's lips are conformed betweenthe second surface and at least one of the tubular portion and the firstsurface when a positive pressure is created inside the mouth to form aseal around the oral adaptor.
 9. An oral adaptor as claimed in claim 8,wherein at least one of the first surface and the second surface is madeof flexible material.
 10. An oral adaptor as claimed in claim 8, whereinthe second surface is made of a more flexible material than the firstsurface.
 11. An oral adaptor as claimed in claim 8, wherein at least oneof the first surface and the second surface is made of an elasticmaterial.
 12. An oral adaptor as claimed in claim 8, wherein the firstsurface is carried by a flange to be placed between the person's teethand lips around the insertion end of the tubular portion.
 13. An oraladaptor as claimed in claim 8, wherein the second surface is carried bya sealing element to be placed on the person's lips around the tubularportion.
 14. An oral adaptor as claimed in claim 8, further comprisingan exhalation port.
 15. A nasal seal comprising two curved pieces to beplaced on respective sides of a person's nose, the curved pieces beingconnected to each other so as to leave a space between them for theperson's nose, wherein a holding strap is attached to the nasal seal forapplication on the person's nose.
 16. A nasal seal as claimed in claim15, wherein the curved pieces are rollers rotatable around respectiveaxes, the axes being connected to each other so as to leave a spacebetween the rollers for the person's nose.
 17. A nasal seal as claimedin claim 16, wherein ends of the holding strap are attached to therespective rollers at a distance from their respective rotation axes, sothat a degree of rotation of the rollers can adjusted by adjusting thestrap.
 18. A nasal seal as claimed in claim 17, wherein the ends of theholding strap are attached to the cylinders such that the rollers rotatein opposite directions when the strap ends are pulled.
 19. A headappliance for a CPAP device, comprising: a mouthpiece having aninsertion portion to be inserted in a person's mouth and a connectionportion to be connected to a CPAP respirator, a connection tube havingan end connected to the connection portion of the mouthpiece, a headstrap to be placed over a persons' head, and a tube support elementattached to the head strap for supporting the connection tube.
 20. Ahead appliance for a CPAP device, comprising: an oral adaptor accordingto claim 1, and a nasal seal.
 21. A head appliance for a CPAP device,comprising: an oral adaptor according to claim 8, and a nasal seal. 22.A CPAP device, comprising: a CPAP respirator, and a head applianceaccording to claim
 19. 23. A CPAP device, comprising: a CPAP respirator,and an oral adaptor according to claim
 1. 24. A method for treatingsymptoms of sleep apnea in a person, comprising: inserting an insertionportion of an oral insert in the person's mouth, applying a sealingelement on the person's mouth so that the person's lips form a tightseal with the insertion portion of the oral insert, and connecting theoral insert to a source of positive pressure.
 25. A method for treatingsymptoms of sleep apnea in a person, comprising: inserting an insertionportion of an oral insert in the person's mouth such that a firstsurface of the insertion portion faces an inner side of the person'slips, applying a sealing element on the person's mouth such that asecond surface of the sealing element faces an outer side of theperson's lips, so that the lips form a tight seal with the insertionportion of the oral insert, and connecting the oral insert to a sourceof positive pressure.